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SANDERSONS THROAT SPECIFIC PASTILLES

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Sandersons throat Specific Pastilles.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active consituents Specification % quantity Unit

Purified Honey Vinegar of Squill Capsicum Tinctire Tolu Tincture Menthol Benzoic Acid Eucalyptus Oil Cinnamic Acid

B.P.C. B.P.C. B.P.C. B.P.C. B.P. B.P. B.P. B.P.C.

7.500 5.000 0.210 0.160 0.080 0.050 0.020 0.002

w/w v/w v/w v/w w/w w/w v/w v/w

3

PHARMACEUTICAL FORM
Pastilles.

4
4.1

CLINICAL PARTICULARS
Therapeutic indications For symptomatic relief of sore throat, hoarseness, loss of voice, catarrh.

4.2

Posology and method of administration One pastille to be dissolved slowly in the mouth as required. Not recommended for children under six years of age.

Can be used for the elderly. No dosage adjustment necessary in case of renal or liver insufficiency, dialysis, concomitant disease. No maximum tolerated daily dose or maximum dose for an entire course of therapy.

4.3

Contraindications None known.

4.4

Special warnings and precautions for use If symptoms persist beyond seven days consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction None known

4.6

Fertility, pregnancy and lactation The is no evidence of safety in human pregnancy, but the product has been in wide use for many years without apparent ill consequence. As with other medicines it may be used during this period provided the benefits outweigh the risks. No problems are anticipated during lactation.

4.7

Effects on ability to drive and use machines None Known.

4.8

Undesirable effects None Known.

4.9

Overdose No specific problem anticipated.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties None applicable.

5.2

Pharmacokinetic properties None applicable.

5.3

Preclinical safety data None applicable.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Pastille base, consisting of :Granulated sugar. Glucose syrup. Modified starch B.P.C. (Maize and Tapioca starch) Cooking fat. Water.

6.2

Incompatibilities None Known

6.3

Shelf life As packaged for sale - 36 months

6.4

Special precautions for storage Store at room temperature not exceeding 25C.

6.5

Nature and contents of container Nett contents 45 gms Sealed bag in an individual carton.

6.6

Special precautions for disposal Not applicable.

7

MARKETING AUTHORISATION HOLDER
Sandersons (Chemists) Ltd. 37 Oakwood Drive Heaton Bolton BL1 5EE

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MARKETING AUTHORISATION NUMBER(S)

PL 00415/5002R

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13th Febuary 1990

10

DATE OF REVISION OF THE TEXT
27th Febuary 1997

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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